HRA is a tool for predicting possible harm that can come from a defective or malfunctioning device.The evaluation g uides FDA in determining the risk to the public from the defective product and appropriate actions for the firm and the FDA to take to protect public health. HHE is a tool for classifying a voluntary recall by a firm.HHEs and HRAs follow the same process and use the same documentation, but they serve slightly different purposes: HHEs and HRAs are designed to reflect the language in the recall regulations and are used specifically for recalls and related safety work. Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs) are the processes that FDA follows to determine the risks of certain device problems and the actions firms should take to resolve them. In either of these cases, FDA must review the risks to determine the actions needed to resolve them. At other times, FDA’s analysis of medical device reports will indicate a greater than expected failure rate. Most often, a firm will notify its customers and FDA that it is issuing a recall. FDA learns of problems with medical devices in different ways.
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